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Was the provincial government pressured by deep-pocketed pharmaceutical conglomerates to kill off the Therapeutics Initiative, an internationally acclaimed drug watchdog agency run out of UBC?

That theory may sound like an outlandish plot from a Hollywood movie, but it gained some credibility during this spring’s provincial election when it was raised by NDP leader Adrian Dix.

He said the “influential” pharmaceutical industry, which donates to and lobbies the B.C. Liberals, incessantly pressured the government to shut down the Therapeutics Initiative (TI).

The TI is a small agency of university scientists who study the safety and efficiency of prescription drugs offered to B.C. residents through Pharmacare. It is one of the few independent organizations in North America that analyzes what’s in our medicine cabinets.

It has been hobbled for nearly a year, since the province cut its funding and blocked access to crucial patient data as part of a high-profile breach of privacy investigation.

The privacy investigation led to the firing of seven Health Ministry employees engaged in pharmaceutical drug research, but none of them worked at the TI.

Dix vowed an NDP government would revive the TI. “It is saving lives, it is saving money, and it is providing an independent voice in an area which is incredibly one-sided,” he said in a recent interview.

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The TI, which questions the safety and efficiency of prescription drugs, claims pharmaceutical companies and people they influence have tried to shut it down since it was formed two decades ago.

In in-depth interviews with The Sun, the two scientists who founded the TI shared stories about the extreme pressure tactics brought to bear against them by drug companies over the years. The most extreme: a request from a top pharmaceutical executive to have one of the founders fired.

“We have been a real thorn in the eye of big pharma,” said TI co-founder Casey van Breemen, former head of UBC’s pharmacology department.

“[But] they’ve bought the government, they’ve bought the university, and they have now basically destroyed proper clinical pharmacology in Canada.”

Van Breemen and the TI’s other supporters claim the agency has saved patients’ lives — and saved taxpayers millions of dollars — by analyzing drug companies’ claims that a new drug is safe and worth more money than older, cheaper brands.

Its detractors, which include pharmaceutical companies, patient advocacy groups and some doctors, claim the TI has always been biased. They argue it has bogged down the drug review process and kept potentially helpful medications out of the hands of chronically ill British Columbians.

Having lost government support, the TI is limping along with temporary funding provided by UBC.

But it can only do limited work without the patient data it requires to conduct reviews.

Even though none of the fired ministry employees worked for the TI, the government says the suspension of the data is “prudent” while it investigates the alleged misuse of patients’ personal information.

“There is still concern about the investigation and how it may touch members of the TI,” the new health minister, Terry Lake, told The Sun.

Access to the data is suspended until the health ministry investigation – which has led to civil lawsuits, union grievances and a possible RCMP probe – is concluded.

“We know there is an unfortunate timeline here, that the TI feels its funding is coming to an end, but we need to be guided by the investigation,” said Lake, who denied his government’s decisions are influenced by pharmaceutical donors.

“Once the investigation is complete, then I think we need to evaluate the continuing role of the TI.”

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The TI was established at UBC in 1994 by the NDP government.

Its main roles were to review evidence about a drug to determine if it provides an advantage over existing drugs; analyze data from B.C. patients to answer questions not addressed in clinical trials by drug companies; and write letters to B.C. doctors and pharmacists to explain what it has learned about a new drug.

The approval (or rejection) of a drug for the Pharmacare list is high-stakes business.

The ministry wants to offer safe drugs while keeping costs low. Drug companies have millions in profits to gain or lose. Patients want fast access to a wide range of pharmaceuticals.

Before co-founding the TI, Dr. Jim Wright was a professor in UBC’s pharmacology department.

He drew a lot of money into the university by conducting trials for the drug companies, from whom he received gifts.

“I did go on trips and I did think I wasn’t being influenced, but I obviously was influenced,” he said.

So when Wright took the role of independently studying drugs at the TI for the government, he completely severed those ties.

“I don’t think you can be friendly and collegial with the drug industry and still be completely unbiased and unconflicted when you are assessing drugs,” he said.

In an effort to remain autonomous, scientists at the TI refuse to speak with pharmaceutical company officials or accept free lunches from drug reps.

The strategy won international praise from some experts, who claim there is not enough independent research into pharmaceutical drugs, one of the fastest-growing portions of B.C.’s huge health budget.

They also argue Health Canada’s testing of drugs at the national level isn’t thorough enough and requires impartial followup.

Critics, though, argue the TI is not transparent nor inclusive, and has an anti-pharma philosophy that resulted in some B.C. patients facing much longer delays for new drugs than in the rest of Canada.

“Medications reviewed by the TI have already been approved for sale in Canada,” Ron Woznow, past executive director of the B.C. Arthritis Society, lamented in 2008.

“People with private insurance or sufficient financial resources can purchase them. Those who depend on B.C. government Pharmacare are left to wait. That is harmful and discriminatory to those who most need help — seniors and low-income citizens.”

Pharmaceutical companies have also complained about the delays.

Van Breemen, head of UBC’s pharmacology and therapeutics department from 1993 to 2002, recalls being a recipient of lavish perks and pressure tactics from drug companies.

In 1997, three years after he and Wright founded the TI, van Breemen said a top executive in a major drug company asked him to fire Wright.

Wright was a professor in van Breemen’s department and a clinical pharmacologist who had produced many critical drug reviews at the TI.

The incident happened, van Breemen said, while he was going to dinner with the drug company executives in Victoria, where they had all flown for a meeting with the health minister.

“The money was thrown around like crazy.”

“And then, as we were walking up to the dinner — we were outside, it was a nice day — the CEO kind of slowed me down so we were not within any hearing distance of anyone else. He asked me, ‘Well, who does Jim Wright report to?’ van Breemen recalled.

“So then he says, this big handsome Oklahoma guy, ‘Why don’t you fire him?’ I sealed my own fate when I answered him, ‘I could do that if you want to institute censorship in the university.’”

Van Breemen said it was implied he would benefit from Wright’s termination. After he refused to comply, an unrelated $400,000 annual contract to do research at UBC for the drug company — which he started before founding the TI — was cancelled.

“They spent a lot of money on me. And that was basically to buy me and to buy influence on drug policy in B.C.,” alleged van Breemen, who has not signed another drug company contract since then.

Van Breemen said he feels free to talk about this incident publicly now because the provincial government no longer pays him to work for the TI, and he is retired from UBC as a professor emeritus.

Drug companies and pharmacies donated nearly $600,000 to the B.C. Liberals over the past eight years — almost 14 times more than they gave to the NDP. And many of the big donors — including Pfizer and Merck — are among the most active lobbyists in Victoria.

The Sun contacted the five drug companies which gave the most money to the Liberals, but all refused to grant interviews about the TI’s past and future, or any role they played in its demise.

Pfizer Canada issued a brief statement that said the company “has no involvement” in the Health Ministry investigation.

The other drug firms referred questions to their main industry association, Canada’s Research-Based Pharmaceutical Companies, which is also a Liberal donor. It refused to comment at length, saying in a brief email that any decisions about the TI are up to the government.

No one objects to the need for drug-safety reviews, said the president of another industry association, which includes pharmaceutical companies.

“The issue tends to be: what is the best vehicle to do that? And is TI the appropriate vehicle?” said Don Enns, president of Life Sciences B.C.

•

Over the course of its 20-year history, the TI was praised by experts around the world for raising red flags about several drugs. It was among the first to warn about serious side effects from the diabetes drug Avandia and the popular arthritis painkiller Vioxx.

The TI’s cautions delayed approval in B.C. of Vioxx, which was later pulled from the market worldwide.

“The TI’s investigation of Vioxx, an anti-inflammatory drug that for some time gained huge success in most markets, revealed evidence of an increase in heart attacks,” three professors — Gordon Guyatt of McMaster University, Joel Lexchin of York University, and UBC’s Patricia Baird — wrote in 2010. “TI warnings proved prescient, and the delay and restrictions indirectly saved an estimated 500 lives [in B.C.].”

The TI was also lauded for safeguarding taxpayers’ money.

An independent UBC study in 2007 found B.C. had the lowest prescription drug rates in the country, saving the province $700 million a year. The British Medical Journal wrote about the report, agreeing that the TI was responsible for these savings.

But Rennie Hoffman of the Better Pharmacare Coalition, a group of 15 societies that lobby for patients in B.C., argued the TI only saved the province money by delaying the approval of drugs — something that hurt ill people. “There is a conflict of interest in the philosophy of the members of the TI in their predisposition against big pharma,” said Hoffman, whose coalition was formed in 1997 to try to speed up patients’ access to new drugs.

TI officials reject claims they are anti-pharma. “I’m on the side of drug development,” van Breemen said. “But I’m not on the side of profit over human suffering.”

By 2008, 14 years after its inception, the TI had a growing number of opponents who waged a war against the agency in newspapers and health journals, as well as a more private battle focused on lobbying the provincial government for change.

As a result, the B.C. Liberals formed a panel to rethink the drug-review process. The makeup of the government’s committee heavily favoured pharmaceutical industry interests.

Its report slammed the TI for being “narrow, insular and resistant to meaningful stakeholder engagement,” and recommended it either be replaced or restricted in the type of work it does. The next year, a review commissioned by the dean of the UBC medical school concluded the TI was highly reputed around the world for its research and education, but also found a polarization of opinions among doctors. Family physicians appreciated the letters the TI sent about the new drugs, while some specialists thought the reviews were restrictive and ignored the advice of experts in the field.

In 2010, the Liberals slashed the TI’s $1 million annual budget by half and restructured B.C.’s drug-review system, reducing the role of the TI and increasing that of doctors, patient groups and pharmaceutical companies. That prompted an outcry from international academics with prestigious credentials, who feared the watering down of the TI.

“Replacing UBC’s Therapeutics Initiative with a process that allows drug companies to further their business interests at public expense will have predictable results,” wrote Marcia Angell and Arnold Relman, Harvard Medical School professors and former editors-in-chief of the New England Journal of Medicine. “First, more drugs will be listed on B.C.’s formulary, and they will be expensive brand-name drugs with long patent lives ... Second, scientific judgment will yield to commercial pressures.”

Allowing pharmaceutical companies a role in drug coverage decisions “is like putting biker gangs in charge of street crime,” Michael McBane, of the public advocacy organization Canadian Health Coalition, said at the time.

The TI still did drug reviews for the government, but had to apply for the contracts. And since the 2010 changes, Wright alleged, the TI’s relationship with the government has diminished and drug policy in B.C. has been weakened.

Opponents of the TI, though, applauded the changes. In a statement to The Sun, Pfizer said it has found the new system “transparent and accountable.”

“There have been improvements in the process over the last few years and expectations from manufacturers on drug submissions are well understood,” said company spokesman Vincent Lamoureux.

Nancy Roper, executive director of the Arthritis Society of B.C., said drug-approval decisions are made more quickly now, and the new system “provides a more formalized decision-making structure than what we had previously under the TI.”

But do societies like Roper’s offer unbiased opinions when many receive donations from drug companies? The Arthritis Society’s website, for example, says it gets grants from a dozen pharmaceutical-related companies.

Roper said the donations don’t influence her agency’s research or educational programs.

Hoffman, of the Better Pharmacare Coalition, said it is proper for drug companies to donate to his member organizations. “Pharmaceutical companies have a moral obligation to assist patient-care organizations. They make a lot of money off those patients,” he said.

The TI operated in a smaller capacity under the new rules until last summer, when it lost data and funding because of the Health Ministry investigation into inappropriate sharing of patient information.

UBC cobbled together money from various sources to keep the TI afloat because it values the work being done by the TI’s staff, all UBC faculty members.

“Any new drug coming out has reams and reams of data that could absolutely overwhelm a practicing clinician, and having a body like the TI apply a rigorous assessment to those data is exceptionally helpful in making therapeutic decisions for patients,” said Dr. Gavin Stuart, dean of the UBC Faculty of Medicine. That isn’t a long-term solution, as the university doesn’t have a spare $500,000 to replace the government funding. Two staff members have been told they must leave if no new money can be found, Stuart said.

Without long-term funding, the TI’s scientists — some of them international academics — will likely continue to do similar research, but it will be impossible to keep the agency together, Wright said.

“This is a travesty,” he added.

UBC is lobbying the government to restore the TI’s access to patient health data, Stuart said.

But that will not happen, the health minister said, until after the investigation is finished. Lake insisted such decisions are not influenced by pharmaceutical donors, offering as proof the Liberals recent move to cut the cost of most generic drugs in the province by 10 percentage points when compared to brand-name equivalents.

“This notion of evil big pharma out there, obviously it is something that we should all be cognizant of, that this is a large industry and obviously there is self-interest that comes into play whenever you have lots of dollars,” he said. “But I certainly would resist the temptation to characterize our decision-making as unduly influenced by big pharma,” said Lake.

During the election campaign, Premier Christy Clark said part of the reason the Liberals cut the TI’s funding was to “respect the private sector,” which the NDP interpreted as bowing to pressure from pharmaceutical companies. The NDP’s Dix campaigned to not only renew the agency’s $1 million annual budget, but double it, if he formed government. “The TI has been under pressure under the Liberals for 12 years, and it is of such value that it forced the Liberals to overcome even some of their donors and ideological biases to maintain it,” he said.

Dix, who injects insulin four times a day for diabetes, appreciates the development of new drugs, but is also grateful for researchers who impartially test how medicine affects patients. “[The TI] is an outstanding agency,” he said.

Answers about the TI’s future could be years away as lawsuits make their way through the justice system.

One of those lawsuits alleges “the Liberal Party was receiving significant contributions from these drug companies, and the province was eliminating drug safety programs that could cause restrictions on sales of the products of these drug companies.”

So, perhaps the courts will determine if the big-pharma-quashes-small-watchdog plot is fact or fiction.

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Did Big Pharma team up to kill B.C.’s drug safety watchdog?

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